Epilepsy, PartialPhase 3COPENCT01891890

Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE)

A Phase 3 study testing Oxcarbazepine, Levetiracetam and Lamotrigine in people with Epilepsy, Partial and Epilepsy, Localization Related, run by Emory University at 14 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Seizures that arise in specific areas in the brain are called Localization Related Epilepsy (LRE) and are the most common seizure disorder in children. Children that receive drug treatment for this disorder may suffer from treatment related side effects which impact their ability to think or concentrate and their… Read more about this study

Who is it for?: Ages 5 to 16 years
Conditions the study is for: Epilepsy, Partial, Epilepsy, Localization Related
What is being tested?: Oxcarbazepine, Levetiracetam and Lamotrigine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 14 sitesUnited States
Study dates: Aug 2013to 23 Oct 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

Age of participant between 5 years, 6 months and 16 years, 0 months at the time of enrollment
Weight is between ≥ 15 kg the lower limit BMI 99th percentile at study entry at study entry
Child has diagnosed epilepsy as defined by one of the following definitions :
At least two unprovoked seizures occurring more than 24-hours apart, or
One unprovoked seizure and a probability of further seizures similar to the general recurrence risk after two unprovoked seizures (approximately 75% or more), or
At least two seizures in a setting of reflex epilepsy

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Child has a diagnosis of Localization Related Epilepsy (LRE) with or without secondary generalization according to International League Against Epilepsy (ILAE) criteria and which may include Benign Rolandic Epilepsy and Benign Occipital Epilepsy or other LREs.
Localization related seizures will be based upon at least one of the following: 1) focal EEG abnormalities (sharp waves, spikes, or slowing) and the absence of generalized spike waves discharges, 2) focal MRI abnormalities other than active cysticercosis, which may include temporal lobe sclerosis, dysembryoplastic neuroepithelial tumor , ganglioglioma, or focal malformations of cortical development, 3) focal neurologic abnormalities, or 4) clinical semiology, which may include Todd's phenomenon, unilateral dystonia, or fencing posture, or distinct aura consistent with localization related seizure onset (e.g., classic déjà vu or bad smell).
Participants must either be antiepileptic drug (AED) therapy naïve or on an AED (excluding benzodiazepines) for 1-week or less. Children may be on a stable dose of psychostimulants at the time of enrollment, but no change in medication, dose, or schedule in 3 months prior to study enrollment, with no anticipated dosing changes during the 6 months of the study. If participants are taking psychostimulants at the time of study entry, they should plan on continuing them for the 6 month duration of the study protocol including the 3-month and 6-month cognitive and behavioral testing time points.
Females of child bearing potential must agree to acceptable forms of birth control, which may include abstinence.
The child's parent/guardian must be able to keep an accurate seizure diary and be able and willing to comply with instructions and study procedures.
Informed consent from the child's legal guardian or legal representative.
Assent will be obtained from children according to each site's institutional guidelines.

Who cannot join

Children with history of primary generalized seizures (absence, myoclonic, drop)
Children with mixed seizure disorder (e.g., Lennox-Gastaut Syndrome)
Children with sensory seizures only (i.e., auras)
Children with 6+ seizures in the previous week
Children with a history of status epilepticus
Children with a history of neonatal seizures

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Children with diagnoses of pervasive developmental disorders (e.g., autism/autism spectrum disorders)
Children with progressive neurological disease (e.g., degenerative, progressive neoplasm)
Children with major medical disease (e.g., Insulin-Dependent Diabetes Mellitus (IDDM), cancer, renal failure)
Children with diseases with cognitive impact (e.g., inborn errors of metabolism, sickle cell disease with history of stroke)
Children with active cysticercosis documented on MRI
Children with cognitive impairment of sufficient severity that, in the opinion of the investigator, would diminish the likelihood of valid test performance (roughly corresponding to Full Scale Intelligence Quotient (FSIQ) less than 70)
Children with suicide attempt(s) at any point during their lifetime
Children with active suicide ideation
Children with chronic use of first generation antihistamines
Children using recreational drugs (including alcohol)
Children not fluent in either English or Spanish
Female children who are pregnant
Female children who are using oral contraceptives for birth control or for any other indication (e.g. acne treatment)

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Children's Healtcare of Atlanta
Atlanta, Georgia, 30342
Children's Hospital Colorado
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21287
Boston Children's Hospital
Boston, Massachusetts, 02115
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Arkansas Children's Hospital
Little Rock, Arkansas, 72205
Le Bonheur Children's Hospital
Memphis, Tennessee, 38105
University of Rochester
Monroe, New York, 14642
Eastern Virginia Medical School
Norfolk, Virginia, 23510
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Virginia Commonwealth University
Richmond, Virginia, 23284
University of California at San Diego
San Diego, California, 92092
Washington University
St Louis, Missouri, 63110
Children's National Medical Center
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

This study will determine whether changes in attention and social interactions are seen in children treated for LRE using three of the most common medications used to treat pediatric LRE. Children who are newly diagnosed with LRE by their doctors and are between the ages of 5 years 6 months and 16 years 0 months will be randomized to receive levetiracetam, lamotrigine, or oxcarbazepine.

There will be 14 study sites throughout the US. Children will undergo evaluation of their thinking and ability to pay attention before and after starting drug treatment for LRE. Regardless of the specific findings, results of this study will provide the information needed to help parents and their clinicians choose treatment options that maximize cognitive abilities in children with LRE, and provide the data needed for practice guidelines to be established on the basis of cognitive side effect risks.

Read the detailed description

This is a prospective multicenter, randomized, open-label, central assessor, parallel-group study of children ages 5 years, 6 months to 16 years, 0 months with newly diagnosed Localization Related Epilepsy (LRE) to establish whether three common antiepileptic drugs (AEDs) used as first line LRE treatment (lamotrigine (LTG), levetiracetam (LEV), or oxcarbazepine (OXC)) are associated with differential cognitive side effects on attention. It is predicted that one AED will be identified with greater negative cognitive effects on attention. The study will also examine whether there are differential risks for drug-related behavior change. The study will address whether 6 month attentional outcomes can be reliably predicted based upon shorter term cognitive change assessed soon after beginning AED therapy, and establish practice effects associated with repeated test exposure when on constant doses of AED.

Children will undergo cognitive testing after study enrollment and no more than a week after AED initiation. Selected measures will be repeated at the first follow up clinic visit after beginning AED treatment, and the primary endpoint will be the attention performance obtained at the subjects' 6 month follow-up clinic visit.

Conditions: Epilepsy, Partial, Epilepsy, Localization Related
Being tested: Oxcarbazepine, Levetiracetam, Lamotrigine
Keywords: Pediatrics
Medical subject headings: Epilepsies, Partial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxcarbazepineDrug
Also called Trileptal
Titration to target dose starting at week 3. Dose increments above target may be made to a maximum of 3 increments with a minimum interval between dose escalations of 2 weeks.
LevetiracetamDrug
Also called Keppra
Titration to target dose starting at week 3. Dose increments above target may be made to a maximum of 3 increments with a minimum interval between dose escalations of 2 weeks.
LamotrigineDrug
Also called Lamictal
Titration to target dose starting at week 11. Dose increments above target may be made to a maximum of 3 increments with a minimum interval between dose escalations of 2 weeks.

Study groups in NCT01891890
Study group	Role	What they receive
Lamotrigine	Active comparator	Lamotrigine 7.0 mg/kg tablets or chewable tablets administered daily in 2 equally divided doses Receives: Drug: Lamotrigine
Oxcarbazepine	Active comparator	Oxcarbazepine 25 mg/kg tablets or liquid administered daily in 2 equally divided doses Receives: Drug: Oxcarbazepine
Levetiracetam	Active comparator	Levetiracetam 30 mg/kg tablet or liquid administered daily in 2 equally divided doses Receives: Drug: Levetiracetam

What is being measured

The primary outcome is the main question the study is designed to answer.

Conners' Continuous Performance Test II (CPT-II) Confidence Index
The Conners' Continuous Performance Test II (CPT-II) is a measure of sustained attention. Letters are individually presented on a computer screen, and participants are instructed to press the space bar when they are presented with any letter except the letter "X". For children younger than 6 years of age at enrollment, the Kiddie CPT will be used in which the child is instructed to press the space bar every time the ball appears on the screen. The outcome measure is a confidence index representing the probability that the respondent has a clinically relevant problem in sustained attention. Possible scores range from 0 to 100. Scores between 40 and 60 are considered inconclusive while scores above 60 indicate that the child exhibits inattentiveness.
Measured: Baseline, Month 6

Secondary outcomes (1)

Child Behavior Checklist
The Child Behavior Checklist is a measure of specific behavioral and emotional problems are rated by the child's parent or guardian. The Child Behavior Checklist examines three domains (Social Functioning, Mood and Anxiety Symptoms, and Externalizing Symptoms) by assessing 118 problem items that describe specific behavioral and emotional problems. Respondents indicate how accurately the statements describe the child by selecting from options on a 3-point Likert-type scale (0=Not True, 1= Somewhat or Sometimes True, or 2=Very True or Often True). Total raw scores are converted to t-scores with a mean of 50 and standard deviation of 10. A t-score of 67 or greater is considered to be in the clinical range for problematic behavior.
Measured: Baseline, Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201323 Oct 2015

First posted3 Jul 2013 (estimated)
Study startAug 2013
Primary completion23 Oct 2015
Study completion23 Oct 2015

Why it stopped: Poor recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Epilepsy, PartialStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01891890
Sponsor's protocol ID: IRB00066541
Other IDs: PCORI 527
Acronym: COPE
Status last verified: Jul 2017
First submitted: 28 Jun 2013
Last updated: 19 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Active, not recruitingPhase 2
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Focal Epilepsy
Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Enrolling by invitationPhase 3
An Open-label Study of XEN1101 in Epilepsy
Focal Epilepsy, Tonic-Clonic Seizures

All Epilepsy, Partial trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE)
ClinicalTrials.gov ID: NCT01891890
Acronym / sponsor ID: COPE / IRB00066541
Conditions: Epilepsy, Partial, Epilepsy, Localization Related
Keywords: Pediatrics
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Poor recruitment
Enrolment: 72 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: Aug 2013
Primary completion: 23 Oct 2015 (actual)
Study completion: 23 Oct 2015 (actual)
First posted: 3 Jul 2013 (estimated)
Results: Posted 19 Sep 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Lamotrigine	Active comparator	Drug: LamotrigineLamotrigine 7.0 mg/kg tablets or chewable tablets administered daily in 2 equally divided doses
Oxcarbazepine	Active comparator	Drug: OxcarbazepineOxcarbazepine 25 mg/kg tablets or liquid administered daily in 2 equally divided doses
Levetiracetam	Active comparator	Drug: LevetiracetamLevetiracetam 30 mg/kg tablet or liquid administered daily in 2 equally divided doses

Who may qualify

Ages: 5 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (13 listed)

Age of participant between 5 years, 6 months and 16 years, 0 months at the time of enrollment
Weight is between ≥ 15 kg the lower limit BMI 99th percentile at study entry at study entry
Child has diagnosed epilepsy as defined by one of the following definitions :
Child has a diagnosis of Localization Related Epilepsy (LRE) with or without secondary generalization according to International League Against Epilepsy (ILAE) criteria and which may include Benign Rolandic Epilepsy and Benign Occipital Epilepsy or other LREs.
Localization related seizures will be based upon at least one of the following: 1) focal EEG abnormalities (sharp waves, spikes, or slowing) and the absence of generalized spike waves discharges, 2) focal MRI abnormalities other than active cysticercosis, which may include temporal lobe sclerosis, dysembryoplastic neuroepithelial tumor , ganglioglioma, or focal malformations of cortical development, 3) focal neurologic abnormalities, or 4) clinical semiology, which may include Todd's phenomenon, unilateral dystonia, or fencing posture, or distinct aura consistent with localization related seizure onset (e.g., classic déjà vu or bad smell).

Key exclusion criteria (19 listed)

Children with history of primary generalized seizures (absence, myoclonic, drop)
Children with mixed seizure disorder (e.g., Lennox-Gastaut Syndrome)
Children with sensory seizures only (i.e., auras)
Children with 6+ seizures in the previous week
Children with a history of status epilepticus

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OxcarbazepineAlso: TrileptalTitration to target dose starting at week 3. Dose increments above target may be made to a maximum of 3 increments with a minimum interval between dose escalations of 2 weeks.	Drug	Oxcarbazepine
LevetiracetamAlso: KeppraTitration to target dose starting at week 3. Dose increments above target may be made to a maximum of 3 increments with a minimum interval between dose escalations of 2 weeks.	Drug	Levetiracetam
LamotrigineAlso: LamictalTitration to target dose starting at week 11. Dose increments above target may be made to a maximum of 3 increments with a minimum interval between dose escalations of 2 weeks.	Drug	Lamotrigine

Primary outcome

Conners' Continuous Performance Test II (CPT-II) Confidence Index
Time frame: Baseline, Month 6
The Conners' Continuous Performance Test II (CPT-II) is a measure of sustained attention. Letters are individually presented on a computer screen, and participants are instructed to press the space bar when they are presented with any letter except the letter "X". For children younger than 6 years of age at enrollment, the Kiddie CPT will be used in which the child is instructed to press the space bar every time the ball appears on the screen. The outcome measure is a confidence index representing the probability that the respondent has a clinically relevant problem in sustained attention. Possible scores range from 0 to 100. Scores between 40 and 60 are considered inconclusive while scores above 60 indicate that the child exhibits inattentiveness.

1 secondary outcome

Child Behavior Checklist
Time frame: Baseline, Month 6

Results and safety

Results posted to the registry on 19 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lamotrigine	24	17
Oxcarbazepine	27	24
Levetiracetam	21	14

Primary outcome: Conners' Continuous Performance Test II (CPT-II) Confidence Index

Time frame: Baseline, Month 6. Mean (Standard Deviation). Unit: Confidence Index

Measure	Lamotrigine n = 24	Oxcarbazepine n = 26	Levetiracetam n = 20
Baseline	58.4 (20.0)	56.7 (21.6)	56.9 (23.9)
After 6 months of treatment	58.1 (23.2)	54.2 (21.7)	54.0 (24.4)

Population analysed: The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the CPT-II.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Information about adverse events experienced by participants was collected from the time the participant began taking the randomized study drug through 30 days after the last study visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lamotrigine	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Oxcarbazepine	0 of 27 (0%)	0 of 27 (0%)	0 of 27
Levetiracetam	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Limitations and caveats (from the sponsor): The study was terminated early due to inability to meet enrollment goals.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Epilepsy, Partial

RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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Active, not recruitingPhase 2
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
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Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David W. Loring, PhD principal investigator

Emory University

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oxcarbazepine, Levetiracetam and Lamotrigine in people with Epilepsy, Partial and Epilepsy, Localization Related, run by Emory University at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Conners' Continuous Performance Test II (CPT-II) Confidence Index (time frame: Baseline, Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01891890.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.